Getting Started Set Up Conduct Close Next Steps

Planning for Closure

Clinical research studies at Massachusetts General Hospital must be closed with the Partners Human Research Committee, which is the hospital’s institutional review board (IRB). In order to properly close a study, a final report must be submitted to the IRB via the continuing review process.

Closing out a study can be a complex process. It is important to note that each entity involved in the study—the Institutional Review Board (IRB), the United States Food and Drug Administration (FDA), Research Management, etc.—may have its own set of requirements and timelines for managing this phase of a clinical research project.

Review each entity’s requirements and outline your process at least six months before study closure so that you are clear about what steps need to be taken, and who will be responsible for each task.

A study can be closed after the last subject completes his/her final study-encounter.

If your study includes a drug, device or biologic overseen by the FDA, the sponsor will collect the final study agent accountability logs and will require a close-out visit and report.

Check with the study sponsor to determine if your investigational product is to be returned or destroyed. There may be a charge for product destruction. Ask for a receipt or email documentation of destruction completion.

To close out a study, remember to complete the following tasks as applicable:

  • Plan for study closure communications with study subjects
  • Inform the Research Pharmacy via email that the study is complete
  • Resolve any outstanding queries from the study sponsor
  • Schedule a close-out meeting with the monitor/sponsor
  • Submit a final report to the sponsor as per the terms of your contract
  • Submit any outstanding charges to the sponsor
  • Reconcile study finances with the sponsor
  • Label and ship frozen specimens
  • Return or discard the remaining lab supplies
  • Notify the IRB of close-out and submit final report
  • Organize and archive case report forms and regulatory documents per storage requirements
  • Report results to ClinicalTrials.gov (if applicable)
  • If case report forms have been electronic, request hard copies or CDs from the sponsor
  • Verify that all regulatory documentation, including IRB documentation, is complete

If you need help generating the data required for ClinicalTrails.gov results reporting, the Clinical Research Program's Biostsatistics Unit can provide free consultation of up to four hours to assist.

Learn More

The Division of Clinical Research (DCR) at Mass General helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCR programs are noted in parentheses.

Resources

Courses

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Additional Support


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